New Delhi: Noting that the study drug Endoxifen is already approved in India since 10-12-2019 for proposed indication, the Subject Expert Committtee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Intas to submit approval letters from other participating countries and revise the protocol.
This recommendation came after the drug major Intas presented a Phase III clinical trial protocol no 72189812, version 02 dated 06-12-2022 before the committee.
The committee noted that the study drug Endoxifen is already approved in India since 10-12-2019 for the proposed indication.
Endoxifen belongs to a group of medications called ‘antipsychotics’ used to treat bipolar disorder. Endoxifen directly blocks protein kinase C activity (which is found to increase in the manic phase of patients with bipolar I disorder) in the nervous system and subsequently helps to manage certain chemicals in the brain such as norepinephrine, serotonin, and dopamine that control your mood.
Endoxifen treats manic or mixed episodes associated with bipolar I disorder in India. It has been found that endoxifen improves manic symptoms as well as mixed episode symptoms of patients with bipolar I disorder and has been considered an effective and well-tolerated treatment for this condition.
At the recent SEC meeting for Neurology and Psychiatry held on March 16th 2023, the expert panel reviewed the Phase III clinical trial protocol of the antipsychotic drug Endoxifen (protocol no 72189812) presented by the drug major Intas Pharma.
After detailed deliberation, the committee recommended that the firm should submit approval letters from other participating countries and revise the protocol as below-
1. The treatment period should be at least 4 weeks.
2. The study design should be 3:1 (Active: Placebo) rather than 1:1.
3. Sample size should be justified and to be re-calculated. Only 10% of the global sample size should be proposed from the country.
4. eGFR test should be carried out at the screening visit.
5. Additional pregnancy tests should be carried out at the start of dosing in women of childbearing potential.
6. Safety management plan to be included in the protocol.
Accordingly, the revised protocol with revised no. of proposed sample size from the country should be submitted to CDSCO for further review by the committee.